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Kalydeco (ivacaftor) – Labelling - R07AX02

Updated on site: 08-Oct-2017

Medication nameKalydeco
ATC CodeR07AX02
Substanceivacaftor
ManufacturerVertex Pharmaceuticals (Europe) Ltd

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON FOR BLISTER

1.NAME OF THE MEDICINAL PRODUCT

Kalydeco 150 mg film-coated tablets

Ivacaftor

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 150 mg of ivacaftor.

3.LIST OF EXCIPIENTS

Contains lactose.

See leaflet for further information.

4.PHARMACEUTICAL FORM AND CONTENTS

56 film-coated tablets

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

INSTRUCTIONS FOR USE

Take one tablet (150 mg) of Kalydeco every 12 hours. Kalydeco should be taken with fat-containing food. Do not break, chew or dissolve the tablets.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Store below 30ºC.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Vertex Pharmaceuticals (Europe) Limited

2 Kingdom Street

London W2 6BD

United Kingdom

Tel: +44 (0) 1923 437672

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/12/782/002

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Kalydeco 150 mg tablets

17.UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18.UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC: {number}

SN: {number}

NN: {number}

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Kalydeco 150 mg tablets

Ivacaftor

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Vertex Pharmaceuticals (Europe) Limited

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON FOR BOTTLE

1. NAME OF THE MEDICINAL PRODUCT

Kalydeco 150 mg film-coated tablets

Ivacaftor

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 150 mg of ivacaftor.

3. LIST OF EXCIPIENTS

Contains lactose.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

56 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

INSTRUCTIONS FOR USE

Take one tablet (150 mg) of Kalydeco every 12 hours. Kalydeco should be taken with fat-containing food. Do not break, chew or dissolve the tablets.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store below 30ºC.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Vertex Pharmaceuticals (Europe) Limited

2 Kingdom Street

London W2 6BD

United Kingdom

Tel: +44 (0) 1923 437672

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/12/782/001

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Kalydeco 150 mg tablets

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC: {number}

SN: {number}

NN: {number}

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING

BOTTLE LABEL

1. NAME OF THE MEDICINAL PRODUCT

Kalydeco 150 mg film-coated tablets

Ivacaftor

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 150 mg of ivacaftor.

3. LIST OF EXCIPIENTS

Contains lactose.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

56 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Store below 30ºC.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Vertex Pharmaceuticals (Europe) Limited

2 Kingdom Street

London W2 6BD

United Kingdom

Tel: +44 (0) 1923 437672

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/12/782/001

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

17. UNIQUE IDENTIFIER – 2D BARCODE

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON FOR SACHET

1. NAME OF THE MEDICINAL PRODUCT

Kalydeco 50 mg granules in sachet

Ivacaftor

2. STATEMENT OF ACTIVE SUBSTANCE

Each sachet of granules contains 50 mg of ivacaftor.

3. LIST OF EXCIPIENTS

Contains lactose.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Granules in sachet

56 sachets

4 individual wallets with 14 sachets per wallet

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

INSTRUCTIONS FOR USE

Take one sachet (50 mg) of Kalydeco granules every 12 hours. Mix the entire content of a sachet with 5 mL of age-appropriate soft food or liquid that is at or below room temperature and consume it completely. Use within one hour after mixing, just before or after a fat-containing meal or snack.

Lift here to open

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

Use within one hour after mixing.

9. SPECIAL STORAGE CONDITIONS

Store below 30ºC.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Vertex Pharmaceuticals (Europe) Limited

2 Kingdom Street

London W2 6BD

United Kingdom

Tel: +44 (0) 1923 437672

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/12/782/003

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Kalydeco 50 mg granules

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC: {number}

SN: {number}

NN: {number}

PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING WALLET FOR SACHET

1. NAME OF THE MEDICINAL PRODUCT

Kalydeco 50 mg granules in sachet

Ivacaftor

2. STATEMENT OF ACTIVE SUBSTANCE

Each sachet of granules contains 50 mg of ivacaftor.

3. LIST OF EXCIPIENTS

Contains lactose.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Granules in sachet

14 sachets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

INSTRUCTIONS FOR USE

Take one sachet (50 mg) of Kalydeco granules every 12 hours.

Mix the entire content of a sachet with 5 mL of age-appropriate soft food or liquid that is at or below room temperature and consume it completely.

Use within one hour after mixing, just before or after a fat-containing meal or snack. Use all 7 days’ doses before starting a new wallet.

Morning

Evening

SUN MON TUE WED THU FRI SAT

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

9. SPECIAL STORAGE CONDITIONS

Store below 30ºC.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Vertex Pharmaceuticals (Europe) Limited

2 Kingdom Street

London W2 6BD

United Kingdom

Tel: +44 (0) 1923 437672

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/12/782/003

13. BATCH NUMBER

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

17. UNIQUE IDENTIFIER – 2D BARCODE

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

SACHETS

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Kalydeco 50 mg granules

Ivacaftor

Oral use

2.METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6.OTHER

Vertex Pharmaceuticals (Europe) Limited

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON FOR SACHET

1. NAME OF THE MEDICINAL PRODUCT

Kalydeco 75 mg granules in sachet

Ivacaftor

2. STATEMENT OF ACTIVE SUBSTANCE

Each sachet of granules contains 75 mg of ivacaftor.

3. LIST OF EXCIPIENTS

Contains lactose.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Granules in sachet

56 sachets

4 individual wallets with 14 sachets per wallet

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

INSTRUCTIONS FOR USE

Take one sachet (75 mg) of Kalydeco granules every 12 hours. Mix the entire content of a sachet with 5 mL of age-appropriate soft food or liquid that is at or below room temperature and consume it completely. Use within one hour after mixing, just before or after a fat-containing meal or snack.

Lift here to open

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

Use within one hour after mixing.

9. SPECIAL STORAGE CONDITIONS

Store below 30ºC.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Vertex Pharmaceuticals (Europe) Limited

2 Kingdom Street

London W2 6BD

United Kingdom

Tel: +44 (0) 1923 437672

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/12/782/004

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Kalydeco 75 mg granules

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC: {number}

SN: {number}

NN: {number}

PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING WALLET FOR SACHET

1. NAME OF THE MEDICINAL PRODUCT

Kalydeco 75 mg granules in sachet

Ivacaftor

2. STATEMENT OF ACTIVE SUBSTANCE

Each sachet of granules contains 75 mg of ivacaftor.

3. LIST OF EXCIPIENTS

Contains lactose.

See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Granules in sachet

14 sachets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

INSTRUCTIONS FOR USE

Take one sachet (75 mg) of Kalydeco granules every 12 hours.

Mix the entire content of a sachet with 5 mL of age-appropriate soft food or liquid that is at or below room temperature and consume it completely.

Use within one hour after mixing, just before or after a fat-containing meal or snack. Use all 7 days’ doses before starting a new wallet.

Morning

Evening

SUN MON TUE WED THU FRI SAT

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

9. SPECIAL STORAGE CONDITIONS

Store below 30ºC.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Vertex Pharmaceuticals (Europe) Limited

2 Kingdom Street

London W2 6BD

United Kingdom

Tel: +44 (0) 1923 437672

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/12/782/004

13. BATCH NUMBER

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

17. UNIQUE IDENTIFIER – 2D BARCODE

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

SACHETS

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

Kalydeco 75 mg granules

Ivacaftor

Oral use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

6. OTHER

Vertex Pharmaceuticals (Europe) Limited

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